FDA approves Supplemental New Drug Application for Spiriva Respimat (tiotropium bromide) in asthma in people age 6 and older- Boehringer

Boehringer announced that the FDA approved Spiriva Respimat (tiotropium bromide) for the long-term, once-daily maintenance treatment of asthma in people age 6 and older. The FDA approved the Supplemental New Drug Application (sNDA) under a priority review designation, and the FDA also granted pediatric exclusivity to Spiriva Respimat in light of the clinical trials conducted by Boehringer.

Spiriva Respimat is not a treatment for sudden asthma symptoms. This FDA approval is based on efficacy and safety data from the Phase II and Phase III UniTinA-asthma clinical development program, which included more than 150 sites globally with over 6,000 patients, including 804 children (aged 6-11 years).